Indian authorities have accused Balaji Amines of manufacturing pharmaceutical-grade propylene glycol (PG) without possessing the necessary drug manufacturing licence, after certain test batches were reportedly found to be substandard. The issue came to light when regulators detected excessive water content in some PG samples that failed to meet pharmaceutical specifications. Although no contamination by toxic substances such as ethylene glycol or diethylene glycol was found, the matter has raised regulatory concerns and prompted closer scrutiny.

In response, Balaji Amines stated that it has authorisation only to produce technical- and food-grade PG and has not supplied any material for pharmaceutical use. The company clarified that it applied for a licence to manufacture pharma-grade PG earlier this year and is awaiting approval.

Officials from federal and state drug departments are said to have visited Balaji’s facility, collected samples for further testing, and recommended regulatory action.

The development comes amid global concern over contaminated cough syrup incidents linked to unsafe excipients. Propylene glycol, a common solvent in pharmaceutical formulations, has been under increased oversight following these safety lapses.

Balaji Amines has denied supplying pharma-grade PG to drug manufacturers and described reports of any investigation as “baseless and misinformed.”